Study of the Infectivity, Safety and Immunogenicity of Two Recombinant, Live-Attenuated, B/HPIV3 Vectored Vaccines Expressing the Fusion Glycoprotein of HMPV Delivered by Nasal Spray to HPIV3-Seropositive Children 24 to <60 Months of Age

Completed · Phase 1 · Has a placebo group

Conditions studied: Human Metapneumovirus, Human Parainfluenza Virus Type 3

In brief

HPIV3 and HMPV are viruses that can cause breathing problems in children. The goal of this clinical trial is to look at the safety of 2 experimental HPIV3/HMPV vaccines in HPIV3-seropositive children ≥ 24 months to \< 60 months of age. Children will receive B/HPIV3/HMPV-PreF-A vaccine, B/HPIV3/HMPV-F-B365 vaccine, or placebo, and participants will not know which study product they have received. The main goals of the study are to find out whether these vaccines are well-tolerated and infectious in HPIV3-seropositive children. The general procedures include daily temperature measurements and daily contact with the participant for the first 28 days, giving a single dose of one of the 2 study vaccines or placebo delivered by nasal sprayer, about 9 in-person visits, a physical examination, 7 clinical assessments, 2 blood samples, 9 nasal swabs and monthly contacts with the participant between Days 29-180. Additional visits may occur if the child has a respiratory illness, fever, or ear infections. The illness visit will include a nasal swab and a clinical assessment.

Key facts

Study ID

NCT06546423

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

24

Starts

2024-07-12

Expected to finish

2025-06-04

Last updated by the study team

2026-04-16

Who can join

Age: 2 and older, up to 5. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• ≥24 months of age and <60 months of age at the time of inoculation
• HAI Screening for HPIV3-neutralizing antibody is obtained within the calendar year of inoculation
• Seropositive for HPIV3 antibody, defined as serum HPIV3 HAI titer >1:8
• Pre-inoculation serum sample for HPIV3-neutralizing antibody specimen is obtained no more than 42 days prior to inoculation
• In good health based on review of the medical record, history, and physical examination at the time of inoculation
• Received routine immunizations appropriate for age based on the Advisory Committee on Immunization Practices (ACIP) Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger
• Growing normally for age as demonstrated on a World Health Organization (WHO) growth chart, AND has a current height and weight above the 3rd percentile for age
• Expected to be available for the duration of the study
• Parent/guardian is willing and able to provide written informed consent

You may not qualify if…

• <24 months of age and >60 months of age at the time of inoculation.
• Born at less than 34 weeks gestation
• Maternal history of a positive HIV test before or during pregnancy.
• Evidence of chronic disease
• Known or suspected infection or impairment of immunological functions
• Bone marrow/solid organ transplant recipient
• Major congenital malformations, including congenital cleft palate or cytogenetic abnormalities
• Suspected or documented developmental disorder, delay, or other developmental problem
• Cardiac abnormality requiring treatment
• Lung disease or reactive airway disease
• More than one episode of medically diagnosed wheezing in the first year of life
• Wheezing episode or received bronchodilator therapy or racemic epinephrine within the past 12 months
• Wheezing episode or received bronchodilator therapy after the age of 12 months
• Previous receipt of supplemental oxygen therapy in a home setting
• Previous receipt of an investigational HPIV3 or HMPV vaccine
• Previous receipt or planned administration of human immunoglobulin within the past 6 months. Receipt of licensed monoclonal antibody products for passive prophylaxis against RSV (e.g., nirsevimab) within the past 6 months is not a cause for exclusion
• Previous receipt of any blood products within the past 6 months.
• Previous anaphylactic reaction
• Previous vaccine-associated adverse reaction that was Grade 3 or above.
• Known hypersensitivity to any study product component
• Member of a household that contains an infant who is less than 12 months of age at the date of inoculation through the 10th day after inoculation
• Member of a household that, at the date of inoculation through the 10th day after inoculation, contains an immunocompromised individual including but not limited to:
• a person who is HIV-infected
• a person who has cancer and has received chemotherapy within the 12 months prior to enrollment
• a person living with a solid organ or bone marrow transplant

Where it is running

• CIR - Rangos, Johns Hopkins Bloomberg School of Public Health — Baltimore, Maryland, United States
• CIR South — Columbia, Maryland, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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